Assessing heart disease and diabetes risk in women during and after pregnancy
Preconception to pOst-partum Study of Cardiometabolic Health in Primigravid PregnancY
This study is trying to see how pregnancy complications like pre-eclampsia affect women's chances of developing heart disease and diabetes later on, by following women who are trying to get pregnant and comparing them to those who aren't.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3500 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 7 sites (Cambridge and 6 other locations) |
| Trial ID | NCT05856318 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women who experience placental complications during pregnancy, such as pre-eclampsia and gestational hypertension, to evaluate their risk factors for developing heart disease and diabetes. The study will recruit women actively trying to conceive and follow them through their pregnancy and up to 12 months postpartum. Additionally, a control group of women not planning pregnancy will be included to compare outcomes. The goal is to understand how placental syndromes impact long-term cardiovascular health and to identify potential preventive measures.
Who should consider this trial
Good fit: Ideal candidates are nulliparous women aged 18 to 45 who are actively considering pregnancy within the next year.
Not a fit: Patients currently pregnant, those with established infertility, or individuals with certain chronic conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for reducing the risk of heart disease and diabetes in women who experience placental syndromes.
How similar studies have performed: Other studies have indicated significant associations between placental syndromes and long-term cardiovascular risks, suggesting this approach is grounded in existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Pregnancy Arm Inclusion Criteria: To be included in the trial the participant must: * Nulliparous (no previous pregnancy beyond 20 weeks' gestation) * Actively considering pregnancy within approximately 12 months * Aged between 18 and 45 years * Ability to consent and willing to participate Pregnancy Arm Exclusion Criteria: The presence of any of the following will preclude participant inclusion: * Currently pregnant * Established infertility * Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI) * Assigned male sex at birth * Autoimmune disease (e.g. rheumatoid arthritis, lupus) * Thrombophilia * Type 1 diabetes * Known advanced chronic kidney disease (stages 4-5) * Malignant hypertension * Clinically manifest CVD (e.g. previous myocardial infarction, stroke) * Active cancer/being treated for cancer currently (other than skin cancer) * Any other condition preventing full participation in the study Non-Pregnancy Arm Inclusion criteria To be included in the trial the participant must: * Nulliparous (no previous pregnancy beyond 20 weeks' gestation) * Not planning to conceive during next 18 months * Aged between 18 and 45 years * Ability to consent and willing to participate Non-Pregnancy Exclusion Criteria The presence of any of the following will preclude participant inclusion: * Currently pregnant * Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI) * Assigned male sex at birth * Autoimmune disease (e.g. rheumatoid arthritis, lupus) * Thrombophilia * Type 1 diabetes * Known advanced chronic kidney disease (stages 4-5) * Malignant hypertension * Clinically manifest CVD (e.g. previous myocardial infarction, stroke) * Active cancer/being treated for cancer currently (other than skin cancer) * Any other condition preventing full participation in the study
Where this trial is running
Cambridge and 6 other locations
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Recruiting)
- NHS Greater Glasgow and Clyde — Glasgow, United Kingdom (Recruiting)
- University College London Hospitals NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
- St George's University Hospitals NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
- Manchester University NHS Foundation Trust — Manchester, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Ian Wilkinson, MD — Cambridge University Hospitals NHS Foundation Trust
- Study coordinator: Heike Templin
- Email: cuh.poppycctu@nhs.net
- Phone: 0044 1223 250874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.